SUN BUM SKIN CARE ESSENTIALS KIT- avobenzone, homosalate, octisalate, octocrylene kit

Sun Bum Skin Care Essentials Kit by

Drug Labeling and Warnings

Sun Bum Skin Care Essentials Kit by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• If used as directed with other sun protection measuress ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin 

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply: 
• after 80 minutes of swimming or sweating
• immediately after towel drying. at least every 2 hours
• children under 6 months of age: ask a doctor

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10 a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients (SPF 30 moisturizing sunscreen lotion)

water, polyglyceryl-6 stearate, dimethicone, cetearyl alcohol, capryloyl glycerin/sebacic acid copolymer, hydrated silica, hibiscus sabdariffa fruit extract, niacinamide, cocos nucifera (coconut) fruit extract, helianthus annuus (sunflower) extract, lactobacillus, lactobacillus ferment, musa sapientum (banana) flower extract, musa sapientum (banana) fruit extract, musa sapientum (banana) leaf extract, musa sapientum (banana) peel extract, musa sapientum (banana) pulp extract, lysolecithin, erythritol, glucose, glycerin, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, cetearyl glucoside, fragrance, polyglyceryl-6 behenate, pullulan, sclerotium gum, tocopherol, xanthan gum, phenoxyethanol, ethylhexylglycerin

Questions?

1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM SKIN CARE ESSENTIALS KIT 
avobenzone, homosalate, octisalate, octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-645

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-645-01	1 in 1 KIT	08/17/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	15 mL

Part 1 of 1

DAILY SUNSCREEN MOISTURIZER SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Item Code (Source)	NDC: 69039-646
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HIBISCUS SABDARIFFA WHOLE (UNII: UH3Z91Y49Y)
LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
NIACINAMIDE (UNII: 25X51I8RD4)
COCONUT (UNII: 3RT3536DHY)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
MUSA X PARADISIACA FLOWER (UNII: DG5B0M0NGY)
BANANA (UNII: 4AJZ4765R9)
MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED)
BANANA PEEL (UNII: 04CM0T683C)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
ERYTHRITOL (UNII: RA96B954X6)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
GLYCERIN (UNII: PDC6A3C0OX)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
PULLULAN (UNII: 8ZQ0AYU1TT)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-646-01	15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/17/2021

Labeler - Sun Bum LLC (028642574)